Strides Pharma Science on Thursday said its subsidiary has received approval from the US health regulator to market Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate capsules, used in the treatment of headache.
Singapore-based Strides Pharma Global Pte Ltd, a wholly-owned unit of the company, has received approval for the product from the US Food and Drug Administration (USFDA), Strides Pharma Science said in a statement.
The product, which will be marketed by Strides Pharma Inc in the US market, is a generic version of Teva's Fioricet with Codeine capsules, it added.
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate capsules are indicated for relief from headache.
According to IQVIA MAT May 2020 data, the US market for the product is around $10 million.
Strides Pharma Science has now 124 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 87 have been approved and 37 are pending for approval.
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